Director, Clinical Monitoring
Precision Medicine Group
full-time
Posted on:
Location Type: Remote
Location: Poland
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Salary
💰 PLN 402,700 - PLN 604,100 per year
Job Level
About the role
- Ensure the development and implementation of action plans and provide developmental/strategic oversight to optimize GCM activities, with a focus on high quality delivery and productivity of individual/team/departmental goals
- Lead regional/therapeutic area project resourcing to ensure proper level and allocation resource is assigned for each project within a region/area
- Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately
- Develop, mentor, manage and coach GCM Managers to progress their skills so that Precision for Medicine quality standards are maintained
- Advocate individual career development, and individual responsibility/accountability
- Oversee GCM quality performance within the assigned hierarchy and implement actions to correct negative trends
- Support the identification of quality risks and issues and recommend/implement corrective action plans as needed to leadership team to address deficiencies in performance of employees
- Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
- Ensure GCM staff within the assigned hierarchy provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems
- Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution
- Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics
- Partner with Talent acquisition to ensure adequate levels of candidates and ad-hoc interview process to select high quality GCM staff
- Ensure appropriate on-boarding training for new GCM staff in conjunction with Human Resources, Clinical Training and other functional areas
- Represent Precision for Medicine in a professional manner
- Manage GCM staff in accordance with Precision for Medicine’s values and policies
- Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans
- Perform other duties as assigned by Leadership
Requirements
- Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline
- At least 12 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience
- Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records
- 6+ years of direct supervisory experience managing CRAs and CRA Managers is expected in candidates for this position
- Experience creating effective development programs for clinical staff
- Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards
- Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%
Benefits
- private medical insurance
- MultiSport Card
- life insurance
- pension
- home working allowance
- vacation
- discretionary annual bonus
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical operationsdata managementelectronic data capture systemsmonitoring experiencegap analysisdevelopment programsevaluation processestraining programsresource allocationmetrics development
Soft Skills
leadershipmentoringcoachingcommunicationcollaborationaccountabilityproblem-solvingstrategic oversightperformance feedbackcareer development